150 Participants NeededMy employer runs this trial

Total Intravenous vs Spinal Anesthesia for Total Knee Replacement

FT
ZX
Overseen ByZheng Xie, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare same-day discharge rates and recovery outcomes across an adult patient population undergoing elective Total Knee Arthroplasty (TKA), and randomized to receive either spinal block anesthesia or Total IntraVenous Anesthesia (TIVA).

Primary Aim: assess same-day discharge rates between study arms (TIVA vs spinal).

Secondary Aim: Postoperative comparison of recovery during PostOperative Anesthesia Care Unit (PACU) admission, diagnostic assessment scores; outcomes related to cognition, hemodynamic stability, pain, nausea and vomiting; analysis of IntraOperative electroencephalogram (EEG) monitoring metrics, e.g., total suppression time, average Bi-spectral Index monitor (BIS) value, Spectral Edge Frequency (SEF); ability for Physical Therapy (PT) evaluation prior to discharge; longterm-followup (LTFU), hospital readmission, return to surgery, etc.; adverse event (AE) monitoring.

Who Is on the Research Team?

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Zheng Xie, MD, PhD

Principal Investigator

University of Chicago, Department of Anesthesia and Critical Care

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have a planned (elective) total knee replacement on one knee. Participants must be able to safely receive either spinal anesthesia or intravenous anesthesia, as determined by their doctors.

Inclusion Criteria

I agree to receive either TIVA or spinal-block anesthesia as assigned.
Able to provide written informed consent
I am 18 years old or older.
See 4 more

Exclusion Criteria

I am not eligible to go home the same day after surgery.
Known allergy or hypersensitivity to study-related medications
I am having a knee surgery that is not my first knee replacement.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Spinal-Block
  • Total IntraVenous Anesthesia (TIVA)

Trial Overview

The study compares two types of anesthesia—spinal block versus total intravenous anesthesia (TIVA)—in patients having knee replacement surgery. Patients are randomly assigned to one group and monitored during and after surgery, including with brain activity tests (EEG).

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG)Active Control2 Interventions
Group II: Arm B - Spinal Block with Electroencephalogram (EEG)Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+